Biospecimen and Medical Data Collection and Tumor Biopsy in Creating Research Tissue Registry in Patients with Inflammatory or Invasive Breast Cancer

Last updated: October 4, 2024
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Carcinoma

Breast Cancer

Treatment

Questionnaire Administration

Biospecimen Collection

Medical Chart Review

Clinical Study ID

NCT00477100
2006-1072
2006-1072
NCI-2018-01784
  • Ages > 18
  • All Genders

Study Summary

This trial studies the biospecimen and medical data collection in creating a research tissue registry in patients with inflammatory or invasive breast cancer. Collecting medical data and storing samples of blood, tissue, and stool from patients with inflammatory breast cancer to study in the laboratory may help doctors find better ways to treat and study inflammatory breast cancer in the future.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with clinical diagnosis of primary inflammatory breast cancer (IBC), secondprimary IBC, or highly suspicious for IBC (MD Anderson patients only).

  • Histological diagnosis of invasive breast cancer, or highly suspicious for IBC (MDAnderson patients only) but pending breast cancer diagnosis.

  • Be either newly diagnosed, or highly suspicious for IBC (MD Anderson patients only) [Cohort I] or have paraffin blocks or up to 20 unstained slides of eachrepresentative block(s) from the time of initial diagnosis of IBC(i.e. core biopsyand punch biopsy) and/or from mastectomy (Cohort II-MD Anderson patients only)

  • Age > 18 years

  • Able to provide informed consent

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 1200
Treatment Group(s): 4
Primary Treatment: Questionnaire Administration
Phase:
Study Start date:
April 17, 2007
Estimated Completion Date:
April 30, 2030

Study Description

PRIMARY OBJECTIVES:

I. To prospectively collect tissue (including primary inflammatory breast cancer [IBC], ipsilateral nodal metastasis and/or distant metastasis [if applicable] obtained prior to primary systemic therapy and mastectomy/axillary dissection), serum, plasma, whole blood, clinical, and imaging data from patients with recently diagnosed inflammatory breast cancer (IBC), or highly suspicious for IBC, who have not received systemic therapy.

II. To collect paraffin tissue blocks or unstained slides (including primary, ipsilateral nodal metastasis and/or distant metastasis [if applicable] obtained prior to primary systemic therapy), mastectomy/axillary dissection tissue, serum, plasma, whole blood, clinical, and imaging data (if available) from patients with previously diagnosed inflammatory breast cancer (IBC), who have been treated or partially treated, but have not had mastectomy and are seeking further treatment in the IBC clinic at M. D. Anderson or participating cancer network sites.

III. To collect oral swab, skin and stool bacterial culture swab for microbiome analysis to compare patients with specific breast cancer subtype to report changes in flora during the course of treatment and correlated to toxicity.

OUTLINE:

Patients complete questionnaires and participate in interview over 30 minutes. Patients also undergo collection of medical data and blood, tissue, and stool samples.

Connect with a study center

  • Sint Augustinus Hospital Cancer Center

    Antwerp,
    Belgium

    Site Not Available

  • Hospital de Cancer de Barretos-Funcacao Pio XII

    Sao Paulo,
    Brazil

    Site Not Available

  • McGill University

    Montreal, Quebec
    Canada

    Site Not Available

  • Institut Paoli Calmettes

    Marseille,
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif,
    France

    Site Not Available

  • Univeristy of Tuebingen

    Tuebingen,
    Germany

    Site Not Available

  • Azienda Ospedaliero-Universitaria Di Cagliari

    Cagliari,
    Italy

    Site Not Available

  • Instituti Europeo di Oncologia

    Milan,
    Italy

    Site Not Available

  • St. Luke's International Hospital

    Tokyo,
    Japan

    Site Not Available

  • Mexico National Cancer Institute

    Mexico City,
    Mexico

    Site Not Available

  • Instituto De Enfermedades Neoplasicas Medical Oncology

    Lima,
    Peru

    Site Not Available

  • Hospital Clinico Universitario de Valencia

    Valencia,
    Spain

    Site Not Available

  • Institute Salah Azaiez

    Tunis,
    Tunisia

    Site Not Available

  • UK London Research Institute

    London,
    United Kingdom

    Site Not Available

  • Banner - MD Anderson Cancer Center

    Gilbert, Arizona 85234
    United States

    Active - Recruiting

  • City of Hope

    Duarte, California 91010
    United States

    Site Not Available

  • Scripps - MD Anderson Cancer Center

    La Jolla, California 92037
    United States

    Site Not Available

  • Banner - MD Anderson Cancer Center - Northern Colorado

    Greeley, Colorado 80631
    United States

    Active - Recruiting

  • Baptist - MD Anderson Cancer Center

    Jacksonville, Florida 32207
    United States

    Active - Recruiting

  • Covenant Medical Center

    Saginaw, Michigan 48604
    United States

    Site Not Available

  • Univeristy of New Mexico

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • MD Anderson in Katy

    Houston, Texas 77094
    United States

    Active - Recruiting

  • MD Anderson League City

    Nassau Bay, Texas 77058
    United States

    Active - Recruiting

  • UT Health Science Center - San Antonio

    San Antonio, Texas 78229
    United States

    Site Not Available

  • MD Anderson in Sugar Land

    Sugar Land, Texas 77478
    United States

    Active - Recruiting

  • MD Anderson in The Woodlands

    The Woodlands, Texas 77384
    United States

    Active - Recruiting

  • Aurora HealthCare Metro Inc. St Luke's Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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